Holder for a dispensing container system

ABSTRACT

A holder for holding a dispensing container system which is adapted to dispense a quantity of a fluid contained therein on movement thereof relative to the holder and further includes a dispensing counter means for counting the number of quantities of the fluid dispensed is disclosed. The holder has a moulded plastic body with inner and outer surfaces. The inner surface bounds a cavity adapted to receive the dispensing container system in movable relation thereto. The cavity has a moulded counter advance means which is adapted in use to engage the dispensing counter means on relative movement between the dispensing container system and the body to advance the dispensing counter means to indicate the dispensing of a quantity of the fluid.

RELATED APPLICATIONS

This International patent application claims priority from UK patentapplication No. 0226020.6 dated 7 Nov. 2002 and is related to theApplicant's concurrently filed International patent applications whichrespectively claim priority from UK patent application No. 0226021.4dated 7 Nov. 2002 (Applicant's Ref: P33143) and UK patent applicationNo. 0226022.2 dated 7 Nov. 2002 (Applicant's Ref: P33144). The entirecontent of each of these applications is hereby incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates to a holder for holding a dispensingcontainer system which is adapted to dispense a quantity of a fluidcontained therein on movement thereof relative to the holder, and isparticularly, but not exclusively, concerned with a holder for holdingan aerosol canister.

BACKGROUND OF THE INVENTION

A holder for an aerosol canister which acts as an actuator for thecanister on relative movement therebetween is known in the field ofinhalation devices, for instance the nasal inhaler marketed under thetrade name Beconase® (GlaxoSmithKline) in which the aerosol canistercontains a drug (beclomethasone dipropionate) formulated in apressurised fluid propellant.

In the Beconase® device the aerosol canister has a canister body holdingthe drug formulation which is capped with a valve assembly comprising avalve stem through which the drug formulation is selectively dischargedfrom the canister body. The valve stem is biased to an extended (closed)position relative to the canister body by a spring or the like in thevalve assembly. In the extended position the valve stem places the drugformulation in fluid communication with a metering chamber in the valveassembly. This is the metering state and the metering chamber is sealedfrom the external environment in this state. The valve stem is movableagainst the biasing force to a retracted (open) position relative to thecanister body. In the retracted position the valve stem places themetering chamber in fluid communication with the external environmentwhereby the metered quantity of the drug formulation in the meteringchamber is exhausted from the canister for administration to thepatient. This is the discharge state and in this state the meteringchamber is sealed from the interior of the canister body.

The holder has a hollow tube-like container part with a cavity whichreceives the canister therein. As known in the art, a base of the cavitypresents a hollow stem block to receive the valve stem in stationaryrelation thereto. An outlet nozzle sized to be received in a patient'snostril extends outwardly from the outer surface of the container part.The stem block has an orifice which is oriented towards the nozzle.

In use, the patient depresses the canister into the cavity of thecontainer part thereby resulting in the canister body moving relative tothe valve stem to bring the valve stem to its retracted position. Thiscauses a metered amount of the drug formulation to be discharged fromthe valve stem and directed out of the nozzle by the stem block to bedelivered to the patient's nostril.

In addition to the container part, the holder has a closure part whichis hinged to the mouth area of the cavity of the container part so as tobe hingeable from a closed position, in which the closure partcooperates with the container part to enclose the canister and thenozzle, to an open position in which the closure and container parts arearranged “back-to-back” to expose the canister and nozzle. In the closedposition the holder acts as a protective casing for the inhalationdevice, while in the open position the patient can use the holder as anapplicator for gripping the inhalation device when administering thedrug.

A drawback of such an inhalation device is that there is no dose counterto count the number of doses of the drug delivered to the patient sothat the number of doses left is known.

It would be useful to provide a holder of the type defined which isadapted to advance a dose counter on relative movement of the dispensingcontainer system thereto.

SUMMARY OF THE INVENTION

According to the present invention there is provided a holder forholding a dispensing container system which is adapted to dispense aquantity of a fluid contained therein on movement thereof relative tothe holder and further includes a dispensing counter means for countingthe number of quantities of the fluid dispensed, the holder having amoulded plastics body with inner and outer surfaces, the inner surfacebounding a cavity adapted to receive the dispensing container system inmovable relation thereto, the cavity having a moulded counter advancemeans which is adapted in use to engage the dispensing counter means onrelative movement between the dispensing container system and the bodyto advance the dispensing counter means to indicate the dispensing of aquantity of the fluid, the body being formed with an outlet port incommunication with the cavity such that the fluid dispensed from thedispensing container system is dischargeable therethrough, and anaperture extends through the body from the outer surface to the innersurface in alignment with the counter advance means.

The aperture is created in the moulding process by that part of themould which forms the counter advance means. The aperture provides themeans by which the mould part is extracted from the body after it hasbeen moulded. This is particularly advantageous where the counteradvance means is unable to be formed by a mould part extending throughthe outlet port, for example due to the size of the outlet port as inthe case where the outlet port is in the form of a nozzle sized to bereceived in a nostril of a nose of a human patient, and/or where thecounter advance means is non-aligned with the outlet port.

The counter advance means may be a rack-like means, for instance arack-like member or post.

In an embodiment of the invention, such as hereinafter described, thecavity extends along an axis of the holder and the dispensing containersystem is axially, slidably movable in the cavity to dispense therefrom.The body may be adapted to receive the dispensing container system inthe cavity only when it is arranged in a predetermined orientation aboutan axis thereof. The axis of the dispensing container system preferablyextends between a trailing end and a leading end of the dispensingcontainer system. The counter means may be located at the leading endand the body adapted to prevent rotation of the counter means in thecavity from the predetermined orientation.

Preferably, the body is provided with an alignment feature for aligningthe system in the predetermined orientation. As an example, thealignment feature may be a slot in the body along which the system isslidable, as in the embodiment hereinafter described. Moreover, the slotmay be adapted to engage the counter means to prevent its rotation inthe cavity.

In an embodiment of the invention, such as hereinafter described, thecounter means has a display part for displaying indicia to indicate thecount and the body has a window for registering with the display part.The window may form part of the alignment feature, e.g. the slot atleast in part extends from the outer surface to the inner surface.Conveniently, it is the display part which is slidable in the slotand/or which the slot engages for anti-rotation of the counter means.

The holder may have a hollow stand structure with a passageway in fluidcommunication with the outlet port, an outlet member of the containersystem through which fluid is dispensed being receivable in thepassageway so that the passageway is able to channel fluid dispensedfrom the outlet member to the outlet port. The passageway may have anentrance opening into which the outlet member is insertable, and an exitopening aligned with the outlet port. The exit opening may be spacedfrom the outlet-port by a void area, as in the embodiment hereinafterdescribed.

In an embodiment of the invention, such as hereinafter described, thecounter advance means and/or stand structure is located on a basesurface of the cavity. The counter advance means may be positioned to aside of the stand structure.

Preferably, the body is formed by injection moulding.

According to the invention there is further provided the holder of theinvention and the dispensing container system or the counter meansthereof. The system may comprise a container and the counter means. Thecontainer and counter means may be secured, fixedly or releasably, toform a unitary structure, or independent parts. In the latter case, thecounter means may be mounted in the cavity, e.g. permanently.

The container may have an outlet member and a container member whichcontains the fluid and is movable relative to the outlet member todispense the fluid from the outlet member. The container system maydispense when the container member is moved relative to the outletmember and the stand structure may be adapted to hold the outlet memberstationary relative to the body so that the container member is movablein the body relative to the outlet member.

Ideally, the outlet member is at the leading end of the containersystem.

As in the embodiment hereinafter described, the container may be anaerosol container, in which case the outlet member may form a part of avalve mechanism secured to the container member which is selectivelyopenable by movement of the container member in the body relative to theoutlet member.

Preferably, the container system has a metering mechanism for dispensingmetered doses of the fluid and the dispensing counter means is adaptedto count the number of doses dispensed. To this end, the valve mechanismmay be a metering valve.

The fluid in the dispensing container system may be a drug orpharmaceutical composition, e.g. a suspension or solution of a drug in aliquified gas propellant, such as HFA 134a or HFA 227. The drug may befor the treatment or prophylaxis of a respiratory disease or disorder,for instance rhinitis.

The present invention-further provides a moulding process for the holderof the invention which has the steps of providing a mould assembly formoulding the holder which includes a mould part adapted in use to formthe counter advance means and the aperture in the moulded holder,moulding the holder in the mould assembly and disassembling the mouldassembly from the holder with the mould part being extracted from theholder through the aperture.

A non-limiting exemplary embodiment of the invention will now bedescribed with reference to the accompanying FIGURES of drawings.

BRIEF DESCRIPTION OF THE DRAWINGS OF THE EXEMPLARY EMBODIMENTS

FIG. 1 is a schematic view of a patient using an intranasal devicehaving an inner actuating part in accordance with the invention.

FIG. 2 is a side view of the intranasal device showing an outer casingpart thereof comprising cover and container members and a hingetherebetween, the outer casing part in a closed state to protect innerparts of the device.

FIG. 3 is a side view of the intranasal device with the outer casingpart hinged to an open state to allow access to the inner parts.

FIG. 4A is a side view of the intranasal device in its open state withthe cover member pivoted behind the container member

FIG. 4B corresponds to FIG. 4A, but with the container and cover membersnested.

FIG. 5 is a rear view of the device with the outer casing part in itsclosed state.

FIG. 6 is an exploded perspective view of the intranasal device with theouter casing part in its nested state.

FIG. 7 is a schematic, partial sectional side view of the inneractuating part of the intranasal device mounted in the outer casingpart.

FIG. 8 is a enlarged fragmentary view of an alternative hingeconstruction for the outer casing part.

FIG. 9 is a cross-sectional side view of the alternative hingeconstruction along line IX-IX in FIG. 8.

FIG. 10A is a perspective view of a canister unit of the intranasaldevice comprising a canister and a dose counter head mounted on thecanister.

FIG. 10B is a plan view of the dose counter head.

FIG. 10C is a side view of the dose counter head.

FIG. 10D is a rear view of the dose counter head.

FIG. 11 is schematic side view, partly in section, of the inneractuating part of the intranasal device.

FIG. 12 is an opposite side view of the inner actuating part with thecanister unit shown mounted therein in ghost.

FIG. 13 is a plan view of the inner actuating part.

FIG. 14 is a rear view of the inner actuating part with the canisterunit mounted therein.

FIG. 15A is a schematic side view, partly in cross section, of thecanister unit mounted in the inner actuating part in an inoperativeposition.

FIG. 15B corresponds to FIG. 15A, but with the canister unit in anoperative position relative to the inner actuating part.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENT

In the FIGURES of drawings there is shown a drug delivery device 1 inaccordance with the present invention, the device 1 in this particularnon-limiting embodiment being an intranasal drug delivery device, asshown graphically in FIG. 1.

As best shown in FIG. 6, the intranasal drug delivery device 1 comprisesas component parts the following:—

-   -   an outer casing part 3;    -   a one-piece inner actuating part 5 which is releasably securable        in the outer casing part 3; and    -   a canister unit 7 releasably securable in the inner actuating        part 5.        Outer Casing Part

Referring to FIGS. 2 to 7, the outer casing part 3 of the intranasaldevice 1 is formed from two shell-like members, namely a containermember 9 and a cover member 11, which are connected to one anotherthrough a hinge 13. The container and cover members 9, 11 eachrespectively present a cavity 17 a; 17 b having a mouth bound by a lipsurface 2 a; 2 b (FIG. 6).

Both the container member 9 and the cover member 11 are formed from aplastics material by injection moulding, although other types ofmoulding processes can, of course, be used. The container and covermembers 9, 11 are preferably both formed from polypropylene with thecontainer member 11 being opaque, but with the cover member 11 beingtransparent or semi-transparent. Other plastics material combinationsare possible, although it is preferable for the cover member 11 to betransparent/semi-transparent for reasons which will become apparenthereinafter.

As shown in FIG. 7, for example, the cover member 11 is integrallyformed with the hinge 13, colloquially known as a “living hinge”, andthe hinge 13 includes a knob 15.

Turning to FIGS. 6 and 7, on an inner surface 19 of the cavity 17 a ofthe shell-like container member 9 there is formed a pair of protrusionsor ribs 21 a, 21 b to co-operate with complementary surfaces of theinner actuating part 5 to form a snap-fit connection between the outercasing part 3 and the inner actuating part 5, as will also be discussedin more detail hereinafter. A first one of the ribs 21 a is disposedtowards an upper end 23 of the container member 9, whereas the other rib21 b is disposed towards a lower end 25 of the container member 9.

Also formed on the inner surface 19 of the cavity 17 a of the containermember 9 are longitudinally extending ribs 27 a, 27 b. The longitudinalribs 27 a, 27 b are disposed on opposing sides of the container member 9and act as anti-rotational retainers on the inner actuating part 5 inthe cavity 17 a.

At the upper end 23 of the container member 9 there is formed a bevel 29through which an aperture 31 extends from an outer surface 33 of thecontainer member 9 to the inner surface 19 of the cavity 17 a. From FIG.7 it will be seen that the aperture 31 is adapted to receive the knob 15on the hinge 13. Although the diameter of the knob 15 is greater thanthe diameter of the aperture 31, the knob 15 is able to be pushedthrough the aperture 31 for capture therein due to the container andcover members 9, 11 being sufficiently resiliently deformable due totheir shell-like nature and the materials used. Moreover, the knob 15 isable to be withdrawn from the aperture 31 upon application of asufficient pulling force thereto for separation of the container andcover members 9, 11.

As shown in FIGS. 2 to 5, the mounting of the knob 15 of the hinge 13 inthe aperture 31 of the container member 9 enables two degrees ofmovement of the cover member 11 on the container member 9 as follows:—

-   (1) Hinging of the cover member 11 from a closed position shown in    FIGS. 2 and 5, in which the respective lip surfaces 2 a, 2 b of the    cavities 17 a, 17 b of the container and cover members 9, 11 abut    one another at an interface 2 c to form an enclosed internal space 8    (see FIG. 7), to an open position shown in FIG. 3, in which the    cavity 17 a of the container member 9 is accessible. As will be    understood from FIGS. 6 and 7, the lip surfaces 2 a, 2 b are each    provided with detent elements 4, 6 which engage with one another in    the closed position to provide a releasable snap-fit fastening of    the container and cover members 9, 11 in the closed position.-   (2) Rotary or pivotable movement of the cover member 11 about the    aperture 31 (pivot axis A-A) from a first angular position    corresponding to the open position shown in FIG. 3 to a second    angular position shown in FIG. 4A in which the cover member 11 is    located behind the container member 9. The cover member 11 is not    able to be pivoted about the pivot axis A-A from its closed position    due to the interengagement of the lip surfaces 2 a, 2 b.

As shown in FIG. 4B, when the cover member 11 is in the second angularposition it is able to nest with the container member 9 by forwardmovement in the direction of arrow B. In other words, the concave cavity17 b of the shell-like cover member 11 is able to slidingly receive theconvex rear surface of the container member 9. In the nesting position,an interference fit is formed between the container and cover members 9,11 to releasable fasten them in the nesting position.

When the container and cover members 9, 11 adopt the nestingconfiguration, an ergonomic unit is formed which is able to be easily,and comfortably, held by a hand 90 of a patient 92, as shown in FIG. 1.In this mode, the outer casing part 3 is able to act as a holder orapplicator of the drug delivery device 1.

As shown in FIG. 5, for example, the outer surface 33 at the rear sideof the container member 9 is provided with a window 35. As will beunderstood from FIGS. 4A and 4B, the window 35 is covered by the covermember 11 when in its second angular position. If the cover member 11 istransparent or semi-transparent, the window 35 is then visible throughthe cover member 11 when in its second angular position.

If need be, an indexing or detent mechanism could be provided forindexing the cover member 11 in one or more predetermined angularpositions about the pivot axis A-A, for instance the first and/or secondangular positions and/or angular positions therebetween. The user wouldthen have a tactile feedback indicating that the cover member 11 is inthe correct angular position, e.g. for nesting with the container member9. One way of achieving the indexing mechanism would be amale-and-female arrangement in which male (or female) surface featuresare formed in the outer surface 33 of the container member 9 at therequired angular dispositions about the pivot axis A-A and one or morecomplementary female (or male) surface features are correspondinglyarranged oh the inner surface of the hinge 13 about the knob 15. Whenthe male feature is located in the, or one of the, female features (orvice-versa), the cover member 11 is indexed in a predetermined angularposition. To move the cover member 11 to a new angular position,rotation of the cover member 11 about the pivot axis A-A causesdisconnection of the first indexing connection until the male and femalefeatures reengage at a new angular position of the cover member 11

By way of example, a “ball-and-socket” indexing mechanism is shown inFIGS. 8 and 9 in which a circular array of protrusions 80 is formed onthe inner surface of the hinge 13 co-axially with the knob 15, and acomplementary circular array of sockets 82 is formed in the outersurface 33 of the bevel 29 on the container member 9 co-axially with thepivot axis A-A. When the protrusions 80 are located in the complementarysockets 82, the cover member 11 is indexed in one of a plurality ofdifferent predetermined angular positions it can adopt about the pivotaxis A-A, for instance the first angular position of FIGS. 2 and 3 orthe second angular position of FIGS. 4A and 4B. The cover member 11 isthen able to be indexed in a new predetermined angular position bypivoting it about the pivot axis A-A to disconnect and re-engage theprotrusions 80 and sockets 82, e.g. from the first angular position tothe second angular position and vice-versa.

In an alternative embodiment, an indexing mechanism may be providedwhich indexes the cover member 11 in an end angular position between thefirst and second angular positions mentioned previously such that thecover member 11 does not cover the window 35 in the container member 9,thereby allowing the window 35 to be viewed by a user of the intranasaldevice 1.

Canister Unit

Turning attention now to FIGS. 10A to 10D, the canister unit 7 comprisesan aerosol canister 10 of standard type which contains a drug formulatedin a fluid propellant, e.g. a liquefied gas propellant such as ahydrofluoro alkane (HFA), for instance 1,1,1,2-tetrafluoroethane(CF₃CH₂F) (known as “HFA 134a”) or 1,1,1,2,3,3,3-heptafluoro-n-propane(CF₃CHFCF₃) (known as “HFA 227”) or a mixture thereof. The drug istypically for the treatment or prophylaxis of respiratory diseases ordisorders, for example rhinitis. The drug may also be for the treatmentor prophylaxis of other types of disease or disorder through systemicaction of the drug. The canister unit 7 further comprises a dose counterhead 12.

The canister 10 has a metal canister body 14 which, as known in the art,e.g. from metered dose inhalers (MDIs), has an open end which is cappedby a valve assembly including a valve stem 16 which is mounted so it ismovable relative to the canister body 14, between a retracted or openposition relative to the canister body 14 in which the drug formulationis discharged from the canister 10 through the valve stem 16, and anextended or closed position relative to the canister body 14 in whichthe drug formulation is prevented from being discharged from thecanister 10.

As known in the art, the valve assembly includes a biasing mechanismsuch as a spring (not shown) for biasing the valve stem 16 to the closedposition. The valve assembly may be such as to further include ametering mechanism which operates so that a metered dose of the drugformulation is discharged when the valve stem 16 is in its openposition. Typically, the valve assembly will have a metering chamber offixed volume which in the closed position of the valve stem 16 is sealedfrom the external environment but in fluid communication with thecanister body 14 whereby the metering chamber is filled with the drugformulation, and which in the open position of the valve stem is sealedfrom the canister body 14 and its contents, but placed in fluidcommunication with the external environment so that the metered dose ofthe drug formulation in the chamber is discharged to the externalenvironment through the valve stem 16.

In this embodiment of the invention the valve assembly is a meteringvalve which dispenses a metered dose of the drug formulation peractuation thereof. A suitable metering valve is disclosed in WO98/29321,the content of which is hereby incorporated herein by reference.

The dose counter head 12 of the canister unit 7 has a hollow plasticsbody 18 of a plastics material which is fixedly secured to the canister10 over the outlet end of the canister 10 having the valve assembly. Thedose counter body 18 is fixed to the canister 10 to prevent it beingtaken off the canister 10, although it is free to rotate about alongitudinal axis D-D of the canister unit 7. The dose counter body 18may be fixed to the canister 10 in the manner described and shown inWO01/28887 (Glaxo/Brand et al), the content of which is herebyincorporated herein by reference.

As best shown in FIG. 10D, the dose counter body 18 is formed with adisplay window 20. The dose counter head 12 further includes a dosecounting mechanism (not shown) in the body 18 which, when actuated,advances a counter 22 thereof located in the window 20. When the counter22 is advanced it results in the dose count shown thereby in the window20 either being incremented to indicate the number of doses dispensedor, more preferably, decremented to show the number of doses left in thecanister 10. The dose counter mechanism can take one of the formsdescribed and shown in WO98156444 (Glaxo/Rand et al or Applicant'sco-pending International patent application No. PCT/EP03/06466(Applicant's Ref: PB60210), the contents of which are incorporatedherein by reference.

An aperture 24 is provided in the outer surface of the dose counter body18 to enable a driver to engage with the dose counting mechanism toadvance the counter 22 when a dose of the drug formulation is dispensedfrom the canister 10 by the inner actuating part 5, as will be describedin more detail hereinafter.

As shown in FIGS. 10A and 10B, the dose counter body 18 comprises askirt-like lower section 26 and a U-shaped upper section 28. The dosecounter body 18 also has a central opening 13 to the U-shaped uppersection 28 through which the valve stem 16 protrudes. It will further beseen from FIGS. 10 c and 10D that the dose counter window 20 is formedin a protrusion 32 in the outer peripheral surface of the U-shaped uppersection 28.

Inner Actuating Part

Attention is now turned to FIGS. 11 to 15B which show the inneractuating part 5. The inner actuating part 5 is of a plastics material,preferably polypropylene, made by a moulding process, preferably byinjection moulding.

As will be seen, the inner actuating part 5 is of tubular constructionhaving a main body 37 defining an axially-oriented cavity 38. The mainbody 37 has an outer surface 39 having a rear section 40 of shape andsize which is complementary to the shape and size of the inner surface19 of the container member cavity 17 a, thereby enabling the inneractuating part 5 to fit snugly in the container member cavity 17 a, asshown in FIGS. 3 and 7, for example. More particularly, the rear section40 of the main body outer surface 39 is provided with a series ofaxially-spaced, circumferential ribs 41 a-c which act as spacers toposition the inner actuating part 5 along a vertical axis C-C in thecontainer member 9, as shown in FIGS. 6 and 7. Moreover, as furthershown in FIG. 7, the uppermost circumferential rib 41 a is adapted to besnap fit underneath the locking rib 21 a on the inner surface 19 of thecontainer member 9.

FIGS. 11 to 13 show that the circumferential ribs 41 a-c are intersectedby longitudinal slots 42, 44. The longitudinal slots 42, 44 arepositioned and sized so as to co-operate with the longitudinal ribs 27a, 27 b on the inner surface 19 of the container member 9 of the outercasing part 3 to prevent rotation of the inner actuating part 5 in thecontainer member 9 of the outer casing part 3.

It will further be seen that the inner actuating part 5 has a footstructure 43 which, as shown in FIG. 7, stands on a base surface 60 ofthe cavity 17 a of the container member 9. The foot structure 43includes a notch 45 on its forwardmost surface 47 which engages with thelocking rib 21 b at the lower end 25 of the cavity 17 a of the containermember 9. When the locking features 21 a, 21 b; 41 a, 45 of thecontainer member 9 and the inner actuating part 5 respectively engagewith one another, the inner actuating part 5 is releasably fixed inplace in the container member 9. Only when a sufficient separation forceis applied is the inner-actuating part 5 released from the containermember 9.

The rear section 40 of the main body 37 of the inner actuating part 5has a longitudinally extending guide slot 49. The guide slot 49 is sizedto slidingly receive the protrusion 32 on the dose counter body 18. Thecanister unit 7 can only be inserted into the inner actuating part 5when the protrusion 32 is aligned with the guide slot 49 in the inneractuating part 5, as shown in FIG. 6. Thus, the guide slot 49 acts as atrack along which the protrusion 32 slidingly moves to insert thecanister unit 7 into the inner actuating part 5 and retract ittherefrom. The guide slot 49 also co-operates with the protrusion 32 toact as an anti-rotation feature which prevents rotation of the dosecounter head 12 in the inner actuating part 5, as will be understood byreference to FIGS. 12 and 13.

As shown in FIG. 13, the inner actuating part 5 also has longitudinalspacers 50 arranged circumferentially about the inner surface of thecavity 38 so that the canister unit 7 is generally co-axially mounted inthe inner actuating part 5.

At the base of the cavity 38 of the inner actuating part 5 there isprovided a hollow support 51 (so-called “stem block”) having a sleeve 52with a bore 53 sized to receive the valve stem 16 of the canister 10. Itwill be appreciated that when the canister unit 7 is inserted axiallyinto the cavity 38, the U-shaped upper section 28 of the dose counterhead 12 encloses the support 51 oh three sides thereof. The hollowsupport 51 includes a hollow extension 55 which extends outwardly at anacute angle α to the outer periphery of the sleeve 52. The extension 55has a bore 57 which opens into the bore 53 of the sleeve 52.

The bore 57 of the extension 55 is co-axial with a longitudinal axis E-Eof a nozzle 59 which extends forwardly and upwardly at an acute angle βto the outer peripheral surface of the body 37 of the inner actuatingpart 5. The acute angles α, β may be the same, or substantially thesame. As shown in FIG. 1, the nozzle 59 is shaped and sized to bereceived in a nostril 94 of a nose 96 of the patient 92.

FIG. 15A shows the canister unit 7 mounted in the inner actuating part 5with the valve stem 16 held in the bore 53 of the sleeve 52 of thehollow support 51. As will be understood by comparing FIGS. 15A and 15B,in operation the canister body 14 (and counter head 12) is depressed inthe direction of arrow F relative to the inner actuating part 5 and thevalve stem 16, the stem 16 being held stationary in the hollow support51. This relative movement of the canister body 14 to the valve stem 16causes a metered dose of the drug formulation to be discharged throughthe valve stem 16 into the bore 53 of the sleeve 52. The drugformulation is then channeled by the extension 55 into the nozzle 59 fordelivery to the patient's nostril 94. The biasing mechanism in the valveassembly causes the canister body 14 to re-adopt the inoperativeposition shown in FIG. 15A on release of the depressing force F readyfor the next actuation cycle.

It can therefore be seen from the above that the inner actuating part 5contains all of the actuating elements for causing actuation of thecanister 10 so that the drug formulation is discharged therefrom intothe patient 92. In other words, the inner actuating part 5 is adapted toactuate the canister 10 when separate from the outer casing part 3.

Moreover, the base of the cavity 38 of the inner actuating part 5 ismoulded with a rack-like post 61 having a serrated outer profile 63(teeth) which co-operates with the dose counter mechanism such that ondepression of the canister body 14 in the inner actuating part 5 to itsoperative position shown in FIG. 15B, the rack-like post 61 drives a cogsystem in the dose counter mechanism (see WO98/56444 and PCT/EP03/06466supra) so that the counter 22 in the display 20 is advanced to reflectthat the canister 10 has been actuated to dispense a dose of thedrug-formulation.

It will be observed from FIGS. 11 to 13, for example, that the main body37 of the inner actuating part 5 has an aperture 100 through a sidethereof which is aligned with the rack-like post 61. The aperture 100 isleft by that member of the inner actuating part mould assembly used toform the post 61. In this regard, it will be gathered from FIG. 13 thatthe post 61 does not register with the nozzle 59. That is to say, thepost 61 is offset to the nozzle axis E-E such that it would not bepossible to have the mould member for the post-61 extracted through thenozzle 59. This is because the nozzle diameter has to be small enough tobe insertable into the patients nostril 94 and the post 61 is positionedto one side of the hollow support 51 which is in registration with thenozzle 59 for fluid communication therebetween.

As will be realised, the rack-like post 61 can be replaced by any othermoulded dose counter mechanism driver structure as dictated by the formof the dose counter mechanism. Accordingly, the dose counter mechanismdriver can take the form of another type of mechanical element, forexample. Again, reference may be had to WO98/56444 supra.

It can be seen from FIG. 2 that once the canister unit 7 is assembledwith the inner actuating part 5 and this assembly snap-fitted into theouter casing part 3, the outer casing part 3 acts as a protective casingfor the canister unit 7 when in its closed state as it preventsactuation of the canister unit 7 and shields the nozzle 59 of the inneractuating part 5.

Operation

To use the intranasal device 1, the patient 92 moves the cover member 11of the outer casing part 3 from the closed position shown in FIG. 2 tothe open position shown in FIG. 3. The cover member 11 is then pivotedto the second angular position shown in FIG. 4A and then nested with thecontainer member 9, as shown in FIG. 4B. Then, as shown in FIG. 1, thepatient 92 grips the outer casing member 3 in one hand 90 and insertsthe nozzle 59 into the nostril 94. The patient 92 then actuates thedevice 1 by depressing the canister body 14 into the inner actuatingpart 5 relative to the valve stem 16 with the index finger 98. Thisresults in a metered dose of the drug formulation being delivered to thenostril.

Actuation of the device 1 can be confirmed by the patient 92 observingwhether the dose counter 22 has been advanced (decremented/incremented).The patient 92 then closes the outer casing part 3 to protect the inneractuating part 5 and canister unit 7 until the next dose is required tobe dispensed.

As will be seen from FIG. 1, when the outer casing part 3 is in its openstate it acts as a holder/applicator for the patient 92 in the sensethat the patient 92 is able to grip the outer casing part 3 in one hand90 and to depress the canister body 14 (and counter head 12) into theinner actuating part 5 with the index finger 98 to cause a dose of thedrug formulation to be dispensed through the nozzle 59 and the counter20 to be incremented/decremented.

One of the numerous advantages of the intranasal device 1 is the use ofseparable outer casing and inner actuating parts 3, 5. Recalling thatthe inner actuating part 5 contains all of the functional features foractuating the canister unit 7, both from a drug delivery and dosecounting point of view, this is the only part which needs to be testedand submitted for regulatory approval. The outer casing part 3 does notaffect the performance of the inner actuating part 5 in any way. Thiswould be in contrast to the case where the outer and inner parts 3, 5are integrally formed. In this instance, any change to the externalshape and configuration after approval would necessitate a newapplication for approval since the alteration may have an adverse effecton the internal functional features, especially if the component ismoulded from a plastics material.

So, the inner actuating part 5 is able to be designed first and then thedecorative outer protective casing part 3 designed afterwards. In thisway, the inner actuating part 5 can be tested and submitted forregulatory approval before the outer casing part 3 is finalised. Thisshortens the lead time for developing an approved drug delivery device.Moreover, the outer casing part 3 can be re-designed to maintain acontemporary appearance etc. without requiring a new round of regulatorytests.

Appropriate drugs (or medicaments) for use in the present invention, forinstance forming part of a pharmaceutical aerosol formulation having afluid propellant, e.g. a HFA propellant, such as HFA 134a or HFA 227,may be selected from, for example, analgesics, e.g., codeine,dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations,e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodiumsalt), ketotifen or nedocromil (e.g. as the sodium salt);—antiinfectivese.g., cephalosporins, penicillins, streptomycin, sulphonamides,tetracyclines and pentamidine; antihistamines, e.g., methapyrilene;anti-inflammatories, e.g., beclomethasone (e.g. as the dipropionateester), fluticasone (e.g. as the propionate ester), flunisolide,budesonide, rofleponide, mometasone (e.g. as the furoate ester),ciclesonide, triamcinolone (e.g. as the acetonide),6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester or6α,9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; antitussives, e.g., noscapine;bronchodilators, e.g., albuterol (e.g. as free base or sulphate),salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g.as hydrobromide), formoterol (e.g. as fumarate), isoprenaline,metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (e.g. asacetate), reproterol (e.g. as hydrochloride), rimiterol, terbutaline(e.g. as sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;PDE4 inhibitors e.g. cilomilast or roflumilast; leukotriene antagonistse.g. montelukast, pranlukast and zafirlukast; [adenosine 2a agonists,e.g. 2R,3R,4S,5R)-2-[6.Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate)]; [α4 integrin inhibitors e.g.(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino] propanoic acid (e.g. as free acid orpotassium salt)], diuretics, e.g., amiloride; anticholinergics, e.g.,ipratropium (e.g. as bromide), tiotropium, atropine or oxitropium;hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines,e.g., aminophylline, choline theophyllinate, lysine theophyllinate ortheophylline; therapeutic proteins and peptides, e.g., insulin orglucagons. It will be clear to a person skilled in the art that, whereappropriate, the medicaments may be used in the form of salts, (e.g., asalkali metal or amine salts or as acid addition salts) or as esters(e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimisethe activity and/or stability of the medicament and/or to minimise thesolubility of the medicament in the propellant.

Preferably, the medicament is for the treatment of inflammatory and/orallergic conditions of the nasal passages such as rhinitis, e.g.seasonal and perennial rhinitis as well as other local inflammatoryconditions such as asthma, COPD and dermatitis. Preferably, themedicament is an anti-inflammatory compound for the treatment of asthmaor rhinitis.

It is to be understood that the exemplary embodiment of the presentinvention outlined above are for the purposes of illustration only, andthat the invention can be modified, varied and take on other guiseswithin the scope of the appended claims. Mindful of this, the use ofreference numerals in the claims is not to be taken as having a limitingeffect on the scope of the claims.

For the avoidance of doubt, the use herein of terms such as “generally”,“substantially”, “about” and the like when referring to a parameter ofthe invention is meant to include the absolute parameter.

1. A holder for holding a dispensing container system which is adaptedto dispense a quantity of a fluid contained therein on movement thereofrelative to the holder and further includes a dispensing counter meansfor counting the number of quantities of the fluid dispensed, the holderhaving a moulded plastics body with inner and outer surfaces, the innersurface bounding a cavity adapted to receive the dispensing containersystem in movable relation thereto, the cavity having moulded counteradvance means adapted in use to co-operate with the dispensing countermeans on relative movement between the dispensing container system andthe body to advance the dispensing counter means to indicate thedispensing of a quantity of the fluid, wherein the body is formed withan outlet port in communication with the cavity such that the fluiddispensed from the dispensing container system is dischargeabletherethrough, and wherein an aperture extends through the body from theouter surface to the inner surface in alignment with the counter advancemeans.
 2. The holder of claim 1 in which the counter advance means is arack-like means.
 3. The holder of claim 2 in which the rack-like meansis a rack-like member or post.
 4. The holder of claim 1 in which thecavity extends along an axis of the holder and the dispensing containersystem is axially, slidably movable in the cavity to dispense therefrom.5. The holder of claim 1 in which the body is adapted to receive thedispensing container system in the cavity only when it is arranged in apredetermined orientation about an axis thereof.
 6. The holder of claim5 in which the axis of the dispensing container system extends between atrailing end and a leading end of the dispensing container system. 7.The holder of claim 6 wherein the counter means is located at theleading end and the body is adapted to prevent rotation of the countermeans in the cavity from the predetermined orientation.
 8. The holder ofclaim 5 in which the body is provided with an alignment feature foraligning the system in the predetermined orientation.
 9. The holder ofclaim 8 in which the alignment feature is a slot in the body along whichthe system is slidable.
 10. The holder of claim 9 in which the slot isadapted to engage the counter means to prevent rotation thereof in thecavity.
 11. The holder of claim 1 any one of the preceding claims inwhich the counter means has a display part for displaying indicia toindicate the count and the body has a window for registering with thedisplay part.
 12. The holder of claim 11 in which the body is adapted toreceive the dispensing container system in the cavity only when it isarranged in a predetermined orientation about an axis thereof, in whichthe body is provided with an alignment feature for aligning the systemin the predetermined orientation and wherein the window forms part ofthe alignment feature.
 13. The holder of claim 1 in which the outletport is in the form of a nozzle.
 14. The holder of claim 13 in which thenozzle is sized to be received in a nostril of a nose of a humanpatient.
 15. The holder of claim 1 wherein the counter advance means isnon-aligned with the outlet port.
 16. The holder of claim 1 furtherhaving a hollow stand structure with a passageway in fluid communicationwith the outlet port, an outlet member of the container system throughwhich fluid is dispensed being receivable in the passageway so that thepassageway is able to channel fluid dispensed from the outlet member tothe outlet port.
 17. The holder of claim 16 wherein the passageway hasan entrance opening into which the outlet member is insertable, and anexit opening aligned with the outlet port.
 18. The holder of claim 17wherein the exit opening is spaced from the outlet port by a void area.19. The holder of claim 1 wherein the counter advance means is locatedon a base surface of the cavity.
 20. The holder of claim 19 furtherhaving a hollow stand structure with a passageway in fluid communicationwith the outlet port, an outlet member of the container system throughwhich fluid is dispensed being receivable in the passageway so that thepassageway is able to channel fluid dispensed from the outlet member tothe outlet port, wherein the stand structure is on the base surface ofthe cavity.
 21. The holder of claim 19 wherein the counter advance meansis positioned to a side of the stand structure.
 22. The holder of claim1 wherein the body is formed by injection moulding.
 23. The holder ofclaim 1 including the dispensing container system.
 24. The holder ofclaim 23 in which the system comprises a container to which thedispensing counter means is secured.
 25. The holder of claim 23 whereinthe container has an outlet member and a container member which containsthe fluid and is movable relative to the outlet member to dispense thefluid from the outlet member.
 26. The holder of claim 25 further havinga hollow stand structure with a passageway in fluid communication withthe outlet port, an outlet member of the container system through whichfluid is dispensed being receivable in the passageway so that thepassageway is able to channel fluid dispensed from the outlet member tothe outlet port, in which the container system dispenses when thecontainer member is moved relative to the outlet member and the standstructure is adapted to hold the outlet member stationary relative tothe body so that the container member is movable in the body relative tothe outlet member.
 27. The holder of claim 25 in which the body isadapted to receive the dispensing container system in the cavity onlywhen it is arranged in a predetermined orientation about an axisthereof, in which the axis of the dispensing container system extendsbetween a trailing end and a leading end of the dispensing containersystem, and in which the outlet member is at the leading end of thecontainer system.
 28. The holder of claim 23 wherein the container is anaerosol container.
 29. The holder of claim 28 including the dispensingcontainer system, wherein the container has an outlet member and acontainer member which contains the fluid and is movable relative to theoutlet member to dispense the fluid from the outlet member, and whereinthe outlet member forms a part of a valve mechanism secured to thecontainer member which is selectively openable by movement of thecontainer member in the body relative to the outlet member.
 30. Theholder of claim 23 wherein the container system has a metering mechanismfor dispensing metered doses of the fluid and the dispensing countermeans is adapted to count the number of doses dispensed.
 31. The holderof claim 29 wherein the valve mechanism is a metering valve.
 32. Theholder of claim 23 wherein the fluid is a drug composition.
 33. Theholder of claim 1 in which the body is moulded in a mould having a mouldpart which moulds the counter advance means, the mould part beingarranged in the mould so that it leaves the aperture in the body toenable its extraction from the body after the body has been moulded. 34.A holder assembly for a dispensing container system having an outer partand an inner part in the form of the holder of any one of the precedingclaims, the inner part being receivable in the outer part in anoperational position in which the aperture is covered by the outer part.35. The holder assembly of claim 34 wherein the outer part is movablebetween a closed state, in which the outer part is able to encapsulatethe inner part when in the operational position and a dispensingcontainer system held by the inner part, and an open state, in which thedispensing container system is uncovered thereby enabling it to be movedrelative to the inner part for dispensing a quantity of fluid therefromand advancement of the dispensing counter means.
 36. (canceled)